Biopsy capsules



Sept. 17, 1968 J. M. DREMANN BQIOPSY CAPSULES 2 Sheets-Sheet 1 Filed Dec. 16, 1965 447' O PA Ey INVENTOR. {5345/14. fi/iE/HA IY/V I Sept. 17, 1968 J. M. DREMANN BIOPSY CAPSULES 2 Sheets-Sheet 2 Filed Dec. 16, 196

United States Patent 3,401,684 BIOPSY CAPSULES Jules M. Dremann, Birmingham, Mich., assignor, by mesne assignments, to Edward Week & Company, Inc., Long Island City, N.Y., a corporation of Delaware Filed Dec. 16, 1965, Ser. No. 514,332 4 Claims. (Cl. 128-2) This invention relates to improvements in biopsy capsules for use in taking multiple mucosal biopsies from a plurality of locations in the gastrointestinal tract of a patient with the capsule in situ.

The primary object of the instant invention is to provide an improved biopsy capsule for taking multiple mucosal biopsies at a single intubation, which may be readily and easily intubated, which admits of rapid specimen retrieval, and which employs a concentric double lumen tube whereby to assure complete flexibility of the tube both during intubation and gravity placement of the capsule in the particular locations where biopsies are to be taken.

Another object of the invention is to provide a simply constructive inexpensive positive operating biopsy capsule employing a self-aligned guided piston-cutter and valve element which substantially eliminates all possibility of binding or malfunctioning of the piston-cutter element while taking either one or a plurality of biopsies during a single intubation of the patient.

Other objects of the invention will become apparent by reference to the following detailed description taken in connection with the accompanying drawings, in which:

FIG. 1 is a greatly enlarged longitudinal sectional view of a biopsy capsule embodying the invention shown in its piston-cutter Retracted position.

FIG. 2 is a cross sectional view taken on the line 22 of FIG. 1.

FIG. 3 is a fragmentary cross sectional view taken on the line 33 of FIG. 1.

FIG. 4 is a substantially full size elevational view of the biopsy capsule showing the double lumen concentric tube extending therefrom.

FIG. 5 is a longitudinal sectional view similar to FIG. 1 showing the piston-cutter element in its End-of-Cut position.

FIG. 6 is a longitudinal sectional view similar to FIGS. 1 and 5 with the piston-cutter element in its Flush positron.

Referring now to the drawings wherein like reference characters refer to like and corresponding parts throughout the several views, the particular biopsy capsule 10 illustrating the invention consists of a three-part housing 11 including a cylindrical shell 12, and a nose 13 and an end cap 14 each threaded in hermetically sealed relationship in opposite ends of the said shell 12. A cylindrical piston-cutter element 15 is reciprocatingly mounted within said cylindrical shell 12, and is formed with an annular knife or cutting edge 150 located at the forward end thereof disposed adjacent and in substantial sliding contact with the inner wall of the said cylindrical shell 12. The said shell 12 is provided with a mucosa receiving aperture 120 in the wall thereof formed and located to permit a spear of mucosa, shown more or less diagrammatically at M in FIG. 1, to be drawn by vacuum into the shell 12 when the piston-cutter element 15 is in its Retracted position as shown in FIG. 1. The said spear of mucosa M is cut off by the knife or cutting edge 150 of the piston-cutter element 15 when it is advanced under hydraulic pressure to its End-of-Cut position shown in FIG. 5.

The said piston-cutter element 15 is preferably axially bored at 152 and counterbored at 151, and is reciprocally ice mounted in the cylindrical shell 12 on a hollow generally floating by-pass valve stem 16 having a central passage 160 therethrough, the said hollow bypass valve stem 16 extending through the bore 152 and counterbore 151 of the piston-cutter element 15. The cap 14 is axially bored at 140, and is diametrically bored at 141 at the threaded portion thereof. The axial bore in the cap 14 is of a suflicient diameter and depth to freely accommodate the rear end of the hollow by-pass valve stem 16 leaving a fluid passage 142 therearound. The diametric bore 141 in the cap 14 accommodates a pivot pin 17 which extends substantially through the said diametric bore 141. The said pivot pin 17 extends relatively freely through a diametric bore 161 in the hollow by-pass valve stem 16 located near the rearward end thereof, thus pivotally anchoring the rearward end of the said hollow bypass valve stem 16 to the said cap 14 leaving it free to move longitudinally of the said pivot pin 17 whereby to permit any minute misalignment of the piston-cutter element 15 and/or the by-pass valve stem 16 to be selfcorrecting thereby assuring freedom of reciprocation of the piston-cutter element 15 at all positions thereof, A second diametric bore 162 is provided through the said hollow by-pass valve stem 16, is disposed normal to the first mentioned diametric bore 161, and serves as a fluid passage between the central passage of the hollow bypass valve stem 16 and the fluid passage 142 therearound. The outer end of the said end cap 14 may be suitably formed as at 143 to provide means by which a mercury filled balloon or the like may be secured thereto, or the outer end of the said cap 14 may be dome shaped if and when no mercury balloon is employed.

The hollow by-pass valve stem 16 extends beyond the forward end of the piston-cutter element 15 when said piston-cutter element :is fully Retracted as indicated in FIG. 1. The free outer end of the said hollow by-pass valve stem 16 is preferably flared as at 163 providing a stop for a resilient washer or quadring 18 telescoped over the said hollow by-pass valve stem 16. The said quadring 18 is seated in the counterbore 151 of the piston-cutter element 15, and is maintained in such seated position by such means as a retainer ring 19 press fitted in the said counterbore 151 of the piston-cutter element 15. The forward portion of the bypass valve stem 16 is provided with a plurality of longitudinal grooves preferably as shown in the drawings to provide fluid channels 164 between the Pressure Chamber A and the Cut and Flush Chamber B of the cylindrical shell 12 of the biopsy capsule 10, the said fluid channels 164 also serving as valve ports shown open at 1640 when the piston-cutter element 15 has been moved hydraulically to its Flush position as shown in FIG. 6. The function of the resilient quadring 18 is to return the pist0n cutter element 15 to a valveclosed position shown in FIG. 6 upon the completion of the Plush cycle of operation of the biopsy capsule 10 as hereinafter described. The said resilient quadring 18 also serves to bring the piston-cutter element 15 to a slow cushioned stop at the end of its forward movement to its full Flush position shown in FIG. 6. An extension tube 20 is firmly telescoped into the flared end of the hollow by-pass valve stem 16 to permit the small central pressure-vacuum lumen 210 of a double lumen tube 21 to be telescopingly connected thereto at the distal end thereof. The double lumen tube 21 preferably consists of a small central pressure-vacuum lumen 210 freely telescoped through a larger outer drain-vacuum lumen 211-both preferably radio opaque.

The nose element 13 is preferably formed with a substantially longitudinally central flange 130 On the outer periphery thereof, an inner 'stem 131 threaded in her- 'metically sealed relationship within the outer end of the cylindrical shell 12, and a somewhat smaller outer stem 132 extending outwardly from the said flange 130. The inner diameter 1320 of the outer stem 132 of the nose element 13 is sufliciently larger than the outer diameter of the extension tube 20 of the hollow by-pass valve stem 16 and the central pressure-vacuum lumen 210 of the double lumen tube 21 to permit mucosa samples to pass through the drainage passage 133 into and through the outer drain-vacuum lumen 211 of the double lumen tube 21 as hereinafter described in detail.

The inner diameter of the inner stem 131 of the nose element 13 is preferably flared at 1310 to direct fluid and mucosa samples from the piston-cutter element 15 through the drainage passage 133 into and through the drain vacuum lumen 211 of the double lumen tube 21. The said drain-vacuum lumen 211 of the double lumen tube 21 is telescoped over the outer stem 132 of the nose element 13, and is held in hermetically sealed relationship thereover by such means as an anchorage element 22 which frictionally engages the said drain-vacuum lumen 211 and squeezes portions thereof into a plurality of longitudinally spaced circumferential grooves 1321 preferably provided in the outer portion of the said outer stem 132. The outer portion of the anchorage element 22 of the nose element 13 is preferably bullnosed in shape to provide a smooth transition from the outer periphery of the double lumen tube 21 and the outer surface of the cylindrical shell 12 of the biopsy capsule 10.

In taking either one or a multiple of biopsies, a suitable length of the double lumen tube 21 is first properly anchored to the biopsy capsule 10 of the invention, and the double lumen tube 21 and biopsy capsule 10 is flushed out. The biopsy capsule 10 is then administered to the patient by the patient swallowing it simultaneously with intubation of the patient until it arrives and becomes located with the aid of gravity at the desired location in the patients gastrointestinal tract, all under the direction of a physician or surgeon, and preferably after suitable period of fasting of the patient followed by a mild sedation. After a suitable period of time, the location of the biopsy capsule may be checked either radiographically or fluoroscopically as may be required to assure the taking of biopsies at the specific desired location or locations. When taking more than one biopsy during a single intubation, relocation of the biopsy capsule may require additional radiographic or fluoroscopic checking.

The small central pressure-vacuum lumen 210 of the double lumen tube 21 is selectively connected to a variable source of fluid pressure and vacuum such as a pressure pump and a vacuum pump, not shown. It has been found that a vacuum of 15" to 25" HG in the pressurevacuum lumen 210 is generally adequate to retract the piston-cutter element 15 to its Retracted positionshown in FIG. 1. It also has been found that a pressure of 100 to 150 p.s.i. in the pressure-vacuum 210 lumen is adequate to advance the piston-cutter element 15 to its End-of-Cut and to its Flush positions shown in FIGS. and 6 respectively.

The large outer drain-vacuum lumen 211 is selectively connected to an unpressurized drain or container to dispose of water or other fluid passing through the biopsy capsule 10 when its piston-cutter element is in its Flush position shown in FIG. 6 and to retrieve the biopsy specimen, or, the said outer drain-vacuum lumen 211 is connected to a variable source of vacuum of 1 to 4" HG which has been found necessary and adequate to draw a spear of mucosa M through the mucosa aperture 120 of the cylindrical shell 12 of the biopsy capsule 10 into the Cut and Flush Chamber B when the piston-cutter element 15 is in its Retracted position as shown in FIG. 1.

The foregoing pressures and vacuums are to be considered examples and not limiting, and, while the pressure and vacuum sources, not shown, are capable of Producing such positive and negative pressures they are preferably provided under suitable variable controls. In using the biopsy capsule 10, it has been found preferable to apply the vacuum and pressures gradually; therefore, it is desirable to have the pressure and vacuum lines suitably gaged so that the application of pressures and vacuums during the taking of biopsy specimens and the retrieval thereof may be so applied.

After a patient has swallowed a biopsy capsule 10 with the double lumen tube 21 properly connected thereto and the patient has been intubated to the extent required to locate the biopsy capsule properly at the site a biopsy is to be taken, the small central pressure-vacuum lumen 210 is connected selectively to a source of high fluid pressure HPS or to a source of high vacuum HVS such as suitable pressure or vacuum pumps respectively, and, the larger outer drain-vacuum lumen 211 is connected selectively to a drain D arranged to retrieve the biopsy specimen when flushed from the biopsy capsule 10 or to a source of low vacuum LVS.

The biopsy capsule 10 is then flushed out by applying relatively high pressure from the HPS to the pressurevacuum lumen 210 while the drain-vacuum lumen 211 is open to the drain D, and, during such flushing out, the piston-cutter element 15 is fully advanced to its Flush position shown in FIG. 6. After such flushing out, the biopsy capsule 10 is made ready for the taking of a biopsy by applying relatively high vacuum from the high vacuum source HVS to the pressure-vacuum lumen 210 which retracts the piston-cutter element 15 to its Retracted position shown in FIG. 1. After the said piston-cutter element 15 has been retracted, a spear of mucosa M is drawn through the mucosa aperture in the cylinder shell 12 into the Cut and Flush Chamber B by applying a relatively low vacuum from the low vacuum source LVS to the drain-vacuum lumen 211. After the spear of mucosa M has been drawn into the said Cut and Flush Chamber B, a relatively high pressure from the high pressure source HPS is applied to the pressure-vacuum lumen 210 which advances the piston-cutter element 15 rapidly forwardly (to the right as viewed in FIG. 5) to its End-of-Cut position cutting off the mucosa spear M leaving it in the said Flush Chamber B only momentarily as continued relatively high pressure from the relatively high pressure source HPS continues to advance the piston-cutter element slowly under resistance of the resilient quadring 18 to its Flush position shown in FIG. 6. Plush fluid now passes from the Pressure Chamber A through the valve ports 1640 and fluid channels 164 into the Plush Chamber B and out the drain-vacuum lumen 211 of the double lumen tube 21 to the drain D arranged to retrieve the mucosa specimen.

After obtaining one biopsy specimen, the biopsy capsule 10 may be relocated in the patients gastrointestinal tract to take one or more subsequent biopsies as aforesaid after which the biopsy capsule 10 is carefully withdrawn by means of the double lumen tube 21 from the patients gastrointestinal tract through the patients mouth.

By use of the double lumen tube 21, the intubation of the patient and location of the biopsy capsule 10 within the patients gastrointestinal tract is much easier than with a tube employing more than two lumens. Also, the substantial concentricity of the two lumens of the double lumen disposed freely one within the other along the length of the double lumen tube 21 provides the desired flexibility of the said double lumen tube for patient comfort, and, at the same time permitting greater accuracy in the location of the biopsy capsule than could be accomplished with other types of tubing. Furthermore, the particular construction of the piston-cutter element and the concentricity and adequacy of the fluid passages therewithin provides assurance of positive multiple functioning of the biopsy capsule 10 during the taking of multiple biopsies during a single intubation.

Although but a single embodiment of the invention has been disclosed herein, it is obvious that many changes may be made in the size, shape, arrangement and detail of the various elements thereof, all within the scope of the appended claims.

I claim:

1. Means for taking one or a plurality of mucosa specimens from the gastrointestinal tract of a patient subsequent to swallowing of a biopsy capsule with a single intubation of the patient consisting of a biopsy capsule comprising a housing including a cylindrical shell, and a nose element and a cap threaded in opposite ends thereof, said cap having a central axially disposed recess formed in the inner threaded end thereof,

a cylindrical piston-cutter element reciprocally mounted in said cylindrical shell hydraulically movable to and from a Retracted, End-of-Cut and Flush position formed with an annular cutting edge at the forward end thereof disposed adjacent the inner wall of said cylindrical shell, said piston-cutter element dividing said shell into a pressure chamber at the rearward end of said piston-cutter element and a flush chamber at the forward end thereof,

said cylindrical shell having a mucosa receiving aperture in the wall thereof formed and located to permit a spear of mucosa to be drawn by vacuum into said shell when said piston-cutter element is in its Retracted position to be cut off upon the advancing of said piston-cutter element by hydraulic pressure applied thereto to move it to its End-of-Cut position, a central hollow by-pass valve stem and means pivotally and fioatingly mounting the same at its inner end in said recess formed in said cap,

said hollow by-pass valve stem having an aperture therein opening into said recess in said cap providing a fluid passage communicating from said hollow bypass valve stem to the rearward end of said pistoncutter element,

said piston-cutter element being centrally bored and counterbored from the forward cutter end thereof and reciprocally mounted at said bore over said central hollow by-pass valve stem,

a resilient annular washer element reciprocally disposed in frictional contact around said central hollow bypass valve stem, and means fixing said annual washer element in said piston-cutter element counterbore adjacent the base and outer wall thereof,

said central hollow by-pass valve stem having an outwardly flared free end and longitudinally disposed fluid channels formed in the outer wall at the free end portion thereof providing communication between the pressure chamber and the flush chamber of the biopsy capsule when said piston-cutter element is advanced under hydraulic pressure to its flush position therein,

said resilient washer means being compressed during said advance under hydraulic pressure of the pistoncutter element from its End-ofCut to its Flush position, resiliently returning said piston-cutter element to its End-of-Cut position after said hydraulic pressure is released,

an extension tube extending forwardly from said hollow by-pass valve stem,

a double lumen tube including a central pressure-vacum lumen and an outer vacuum-flush lumen connected respectively to said hollow by-pass valve stem extension tube and the interior of the outer end of said cylindrical shell,

said pressure-vacuum lumen being connectable selectively to a variable pressure or to a vacuum source, and said vacuum-flush lumen being connectable selectively to a variable vacuum source or to a specimen retrieve element and drain.

2. Means for taking one or a plurality of mucosa specimens as claimed in claim 1 wherein the resilient annular washer element disposed in said counterbore of said piston-cutter element in frictional contact around said central hollow by-pass valve stem is in the form of a quadring.

3. Means for taking one or a plurality of mucosa specimens as claimed in claim 1 wherein the double lumen tube consists of a central pressure-vacuum lumen freely telescoped within an outer vacuum-flush lumen.

4. Means for taking one or a plurality of mucosa specimens as claimed in claim 1 including means for selectively connecting the central pressurevacuum lumen to a relatively high pressure source or a relatively high vacuum source, and means for selectively connecting the outer vacuum drain lumen to a relatively low vacuum source or to a specimen retriever drain.

References Cited UNITED STATES PATENTS 2,881,756 4/1959 Crosby et al 128-2 3,033,194 5/1962 Lippert 128--2 3,173,414 3/1965 Guillant 1282 3,289,669 12/1966 Dwyer et a1. 1282 FOREIGN PATENTS 1,161,400 3/1958 France.

OTHER REFERENCES The Lancet, Sept. 24 ,1960 (p. 686). The Lancet, Apr. 25, 1964 (p. 918).

RICHARD A. GAUDET, Primary Examiner.

K. L. HOWELL, Assistant Examiner. 

1. MEANS FOR TAKING ONE OR A PLURALITY OF MUCOSA SPECIMENS FROM THE GASTROINTESTINAL TRACT OF A PATIENT SUBSEQUENT TO SWALLOWING OF A BIOPSY CAPSULE WITH A SINGLE INTUBATION OF THE PATIENT CONSISTING OF A BIOPSY CAPSULE COMPRISING A HOUSING INCLUDING A CYLINDRICAL SHELL, AND A NOSE ELEMENT AND A CAP THREADED IN OPPOSITE ENDS THEREOF, SAID CAP HAVING A CENTRAL AXIALLY DISPOSED RECESS FORMED IN THE INNER THREADED END THEREOF, A CYLINDRICAL PISTON-CUTTER ELEMENT RECIPROCALLY MOUNTED IN SAID CYLINDRICAL SHELL HYDRAULICALLY MOVABLE TO AND FROM A RETRACTED, END-OF-CUT AND FLUSH POSITION FORMED WITH AN ANNULAR CUTTING EDGE AT THE FORWARD END THEREOF DISPOSED ADJACENT THE INNER WALL OF SAID CYLINDRICAL SHELL, SAID PISTON-CUTTER ELEMENT DIVIDING SAID SHELL INTO A PRESSURE CHAMER AT THE REARWARD END OF SAID PISTON-CUTTER ELEMENT AND A FLUSH CHAMBER AT THE FORWARD END THEREOF, SAID CYLINDRICAL SHELL HAVING A MUCOSA RECEIVING APERTURE IN THE WALL THEREOF FORMED AND LOCATED TO PERMIT A SPARE OF MUCOSA TO BE DRAWN BY VACUUM INTO SAID SHELL WHEN SAID PISTON-CUTTER ELEMENT IS IN ITS RETRACTED POSITION TO BE CUT OFF UPON THE ADVANCING OF SAID PISTON-CUTTER ELEMENT BY HYDRAULIC PRESSURE APPLIED THERETO TO MOVE IT TO ITS END-OF-CUT POSITION, A CENTRAL HOLLOW BY-PASS VALVE STEM AND MEANS PIVOTALLY AND FLOATINGLY MOUNTING THE SAME AT ITS INNER END IN SAID RECESS FORMED IN SAID CAP, SAID HOLLOW BY-PASS VALVE STEM HAVING AN APERTURE THEREIN OPENING INTO SAID RECESS IN SAID CAP PROVIDING A FLUID PASSAGE COMMUNICATING FROM SAID HOLLOW BYPASS VALVE STEM TO THE REARWARD END OF SAID PISTONCUTTER ELEMENT, SAID PISTTON-CUTTER ELEMENT BEING CENTRALLY BORED AND COUNTERBORED FROM THE FORWARD CUTTER END THEREOF AND RECIPROCALLY MOUNTED AT SAID BORE OVER SAID CENTRAL HOLLOW BY-PASS VALVE STEM, A RESILIENT ANNULAR WASHER ELEMENT RECIPROCALLY DISPOSED IN FRICTIONAL CONTACT AROUND SAID CENTRAL HOLLOW BYPASS VALVE STEM, AND MEANS FIXING SAID ANNULAR WASHER ELEMENT IN SAID PISTON-CUTTER ELEMENT COUNTERBORE ADJACENT THE BASE AND OUTER WALL THEREOF, SAID CENTRAL HOLLOW BY-PASS VALVE STEM HAVING AN OUTWARDLY FLARED FREE END AND LONGITUDINALLY DISPOSED FLUID CHANNELS FORMED IN THE OUTER WALL AT THE FREE END PORTION THEREOF PROVIDING COMMUNICATION BETWEEN THE PRESSURE CHAMBER AND THE FLUSH CHAMBER OF THE BIOPSY CAPSULE WHEN SAID PISTON-CUTTER ELEMENT IS ADVANCED UNDER HYDRAULIC PRESSURE TO ITS FLUSH POSITION THEREIN, SAID RESILIENT WASHER MEANS BEING COMPRESSED DURING SAID ADVANCED UNDER HYDRAULIC PRESSURE OF THE PISTONCUTTER ELEMENT FROM ITS END-OF-CUT TO ITS FLUSH POSITION, RESILIENTLY RETURNING SAID PISTON-CUTTER ELEMENT TO ITS END-OF-CUT POSITION AFTER SAID HYDRAULIC PRESSURE IS RELEASED, AN EXTENSIION TUBE EXTENDING FORWARDLY FROM SAID HOLLOW BY-PASS VALVE STEM, A DOUBLE LUMEN TUBE INCLUDING A CENTRAL PRESSURE-VACUM LUMEN AND AN OUTER VACUUM-FLUSH LUMEN CONNECTED RESPECTIVELY TO SAID HOLLOW BY-PASS VALVE STEM EXTENSION TUBE AND THE INTERIOR OF THE OUTER END OF SAID CYLINDRICAL SHELL, SAID PRESSURE-VACUUM LUMEN BEING CONNECTABLE SELECTIVELY TO A VARIABLE PRESSURE OR TO A VACUUM SOURCE, AND SAID VACUUM-FLUSH LUMEN BEING CONNECTABLE SELECTIVELY TO A VARIABLE VACUUM SOURCE OR TO A SPECIMEN RETRIEVE ELEMENT AND DRAIN. 